Chemoimmunotherapy Combinations in Elderly Patients with Metastatic Non-Small Cell Lung Cancer and PD-L1 Expression < 50%: Results from an Italian Real-World Study.

Background: Chemoimmunotherapy combinations represent the standard first-line treatment for non-oncogene addicted metastatic NSCLC (mNSCLC). However, evidence in elderly patients remains limited and conflicting. We conducted an analysis of the efficacy and safety of chemoimmunotherapy in patients aged ≥75 years enrolled in the Real-Combo Lung study, an observational study including patients with non-oncogene-addicted mNSCLC and PD-L1 expression < 50%. Patients and Methods: The primary objective of the study was to compare progression-free survival (PFS) and overall survival (OS) between patients aged ≥75 (elderly cohort) and those aged <75 years (non-elderly cohort). Safety outcomes were evaluated as a secondary objective. Results: A total of 495 patients were enrolled, with 89 (18%) aged ≥75 and 406 (82%) aged <75 years. No significant differences in PFS and OS were observed between the two cohorts. The median PFS was 13.3 months (95% CI: 9.3-NR) in the elderly cohort and 10.5 months (95% CI: 9.5-12.9) in the non-elderly cohort (unadjusted HR 0.84, 95% CI: 0.61-1.16, p = 0.29). The median OS was 17.5 months (95% CI: 14.7-NR) versus 21.4 months (95% CI: 17-NR), respectively (unadjusted HR 1.09, 95% CI: 0.76-1.56, p = 0.63). In multivariable analysis, ECOG PS ≥ 2 and baseline use of steroids were significantly associated with a worse outcome in the elderly cohort for both PFS and OS. Safety data did not differ significantly between cohorts. Conclusions: In this real-world study, elderly patients with mNSCLC derived outcomes comparable to those of younger patients, with similar efficacy and a manageable safety profile when treated with chemoimmunotherapy combinations.